MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER WITH BLOOD CONTROL TECHNOLOGY; INTRAVASCULAR CATHETER

Model Number 382512

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Diarrhea (1811); Hepatitis (1897); Nausea (1970)

Event Date 07/27/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the patient had an allergic reaction when the bd insyte¿ autoguard¿ bc shielded iv catheter with blood control technology was used on them to perform a naturopath infusion of vitamins, and sent to the er as a result.Symptoms developed from "30 minutes to 24 hours" after the infusion, and included "flu-like symptoms, diarrhea, nausea, and hepatitis".The patient has reportedly recovered from the incident.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "six patients presented to a local emergency department within 24 hours or receiving an infusion of vitamins from a naturopath.They presented with various degrees of symptoms including flu-like symptoms, diarrhea, nausea and hepatitis.All patients who received this treatment were then interviewed and 17 of the 18 developed symptoms from 30 minutes to 24 hours after the infusion.All have recovered.The investigation expanded to include another city in which this naturopath practiced, and more cases were identified with similar symptom complex and timing.".

Manufacturer Narrative

H.6.Investigation: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record was performed and no quality issues were found during production.H3 other text : see h.10.

Event Description

It was reported that the patient had an allergic reaction when the bd insyte¿ autoguard¿ bc shielded iv catheter with blood control technology was used on them to perform a naturopath infusion of vitamins, and sent to the er as a result.Symptoms developed from "30 minutes to 24 hours" after the infusion, and included "flu-like symptoms, diarrhea, nausea, and hepatitis".The patient has reportedly recovered from the incident.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "six patients presented to a local emergency department within 24 hours or receiving an infusion of vitamins from a naturopath.They presented with various degrees of symptoms including flu-like symptoms, diarrhea, nausea and hepatitis.All patients who received this treatment were then interviewed and 17 of the 18 developed symptoms from 30 minutes to 24 hours after the infusion.All have recovered.The investigation expanded to include another city in which this naturopath practiced, and more cases were identified with similar symptom complex and timing.".

• Brand Name: BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER WITH BLOOD CONTROL TECHNOLOGY
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 10419114
• MDR Text Key: 210225768
• Report Number: 1710034-2020-00522
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825128
• UDI-Public: 30382903825128
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Model Number: 382512
• Device Catalogue Number: 382512
• Device Lot Number: 9213332
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention